BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS VENTILATOR

    MDR report key: 12686568 · Received October 23, 2021

    Report

    Report Number
    3012307300-2021-10197
    Event Type
    Malfunction
    Date Received
    October 23, 2021
    Date of Event
    July 21, 2021
    Report Date
    October 23, 2021
    Manufacturer
    NULL
    Product Code
    QOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE UNIT WAS RETURNED FOR INVESTIGATION. DEVICE SEEMED TO HAVE NORMAL WEAR AND TEAR. THE REPORTED FAULT WAS CONFIRMED AND THE FAULTY MANOMETER WAS REPLACED. ROOT CAUSE TRACED TO WEAR AND TEAR. DHR REVIEW WAS DONE WITH NO OTHER ISSUES REPORTED IN THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRESSURE GAUGE WAS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584764 CONTINUOUS VENTILATOR QOS 510A2357

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown